Treatment of Menstrual Cycle Alterations in Adolescents

the aim of the present study is intended to evaluate how treatment with Myo-Inositol and Dioscorea Villosa can help improve menstrual cycle irregularities in adolescents, both with and without PCOS.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Amenorrhea Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Menstruation Disturbances Neoplasms Oligomenorrhea Ovarian Cysts Ovarian Diseases PCOS (Polycystic Ovary Syndrome) Pathologic Processes Pathological Conditions, Signs and Symptoms Polycystic Ovary Syndrome Urogenital Diseases

Age range

14 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zhordania and Khomasuridze Institute of Reproductology, Tbilisi, Georgia

About this study

The present study aims to evaluate the possible beneficial effect of a treatment with Inofolic HP combined with Inofolic phD on the improvement if menstrual cycle alteration in adolescent patients with or without PCOS.

The molecules chosen for the study are the following: myo-Inositol, α-lactalbumin, Dioscorea Villosa, and Vitamin D, are already commercialized as dietary supplements, commonly administered at same dosage provided in the present study, also for prolonged treatments, with no side effects associated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

adolescent women aged 14-19 years old, with at least 3 years passed after menarche, and oligomenorrhea or amenorrhea

Exclusion criteria

Primary amenorrhea.
Hyperandrogenism due to other factors (i.e. adrenal hyperplasia or Cushing syndrome).
Hyperprolactinemia or overt hypothyroidism (TSH ≥4).
Other hormonal alterations.
Ongoing hormonal therapies, including OCPs, six months before enrollment.
Ongoing pharmacological therapies.
Ongoing use of myo-Inositol supplement or other source of myo-Inositol, or Dioscorea villosa, six months before enrollment.

Treatment and study plan

myo-Inositol plus DIoscorea Villosa

Dietary Supplement

myo-Inositol + alpha-lactalbumin + folic acid once daily, Dioscorea Villosa + alpha-lactalbumin + Vitamin D twice daily

Other names: myo-Inositol, Dioscorea Villosa

Primary outcomes

Menstrual cycle regularity

Time frame: 6 months

The intervention is targed to adolescent patients suffering from menstrual cycle alterations. Particularly, we aim to asses the regularization of the menstrual cycle in those patients with polimenhorrea and oligo-/ amenorrhea, with irregular menstrual cycle (shorter than 21 days or longer than 35 days).

The purpose of the study is to compare the percentage of patients exhibiting a regular menstrual cycle at the end of the treatment period, in the study group vs control.

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Acronym: HP-phD_Adolesc

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jan 29, 2025
Registry last updated: Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed